Kornimate/medical-research-clean huggingface dataset:
photoacoustic imaging for measuring tumors and normal tissue in patients with head and neck cancer

Conditions: Head and Neck Carcinoma; Head and Neck Lymph Node; Head and Neck Squamous Cell Carcinoma; Laryngeal Neoplasm; Radiation Therapy Recipient

Summary: this trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. photoacoustic imaging (pai) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. this study may help doctors determine if pai is correlated with clinical responses of both tumor (for example: shrinking, swelling or disappearing) and normal tissues (for example: skin redness, dry mouth, appearance of sores, healing of skin or mucosa). if there is a correlation with clinical responses, then doctors may develop pai as method for measuring response to earlier treatment.

primary objective: i. define the feasibility of the current photoacoustic imaging (pai) technology in head and neck (h\&n) cancer patients. secondary objective: i. define the utility of the current pai in h\&n cancer patients. outline: part i: patients undergo pai before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy. part ii (cancer-free with xerostomia): patients undergo pai at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (altens) therapy, once after altens, and at 3-6 months follow up.

Eligibility criteria:
inclusion criteria: * no restriction on race or ethnic background * subject must understand the investigational nature of the study and sign an independent ethics committee/institutional review board approved written informed consent prior to receiving any study related procedure * for cancer patients in the h\&n radiation group (part i): * biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (hnscc) getting chemoradiation therapy * presence of neck nodes or laryngeal tumor superficial enough (within 2-3 cm of skin surface) to allow imaging by photoacoustic ultrasound (pa-us) * for altens patients (part ii): * history of prior radiation therapy with xerostomia requiring altens exclusion criteria: * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * unwilling or unable to follow protocol requirements or provide consent * any condition which in the investigator?s opinion deems the subject an unsuitable candidate to undergo imaging procedure
predicting outcomes of gpoem using gastric electrical mapping

Conditions: Gastroparesis

Summary: gastric peroral endoscopic myotomy (gpoem) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. this is a single-arm, multi-centre, prospective observational study to determine the clinical utility of gastric alimetry in predicting gpoem treatment outcomes. the investigators further aim to develop a clinical decision rule to inform patient selection. gastric alimetry will be conducted \<1 month prior to gpoem. all subjects will then be followed up for 12 months.

this protocol proposes no change to the clinical management of patients which is left to the discretion of the patients' primary clinical team. patients as part of this study will undergo a baseline assessment via gastric alimetry, and concurrent symptom, quality of life, and health psychology questions. gpoem will be performed as per standard site protocol, with data captured in rdcap. patients will be followed up at 1-month, 3-month, 6-months, and 12-months using the mycap (redcap) app. participants and clinicians can opt-in for a repeat gastric alimetry test at 6 or 12 months following their gpoem procedure.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * indicated for gpoem exclusion criteria: * pregnant or breast-feeding * inability to perform gastric alimetry test: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined position for the test duration.

Keywords: endoscopy electrophysiology phenotyping
study of forodesine hydrochloride in patients with advanced, fludarabine-refractory chronic lymphocytic leukemia (cll)

Conditions: Leukemia, Lymphocytic, Chronic

Summary: forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). the drug will be administered once daily one hour prior to or two hours after meals. patients will be evaluated after 1 full cycle of therapy (28 days).


Eligibility criteria:
inclusion criteria: * ages 18 years and older * diagnosis of cll established by peripheral blood and bone marrow examination and using the standard criteria * patients with rai stage iii or iv, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy * primary resistance to fludarabine-based therapy (no complete response \[cr\] or partial response \[pr\]) or progressive disease within 6 months of response to prior fludarabine containing regimen. * ecog performance status of 0, 1, 2 or 3 * willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after * all investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug. exclusion criteria: * pregnant or nursing * unable or unwilling to sign consent * severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy * active serious infections that are not controlled by antibiotics * ecog performance status 4 * inadequate renal function: creatinine 2.0 or more unless related to the disease * inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease * known positive test for hiv * patients with known hepatitis b and/or hepatitis c active infection

Keywords: cll chronic lymphocytic leukemia leukemia advanced, fludarabine-refractory cll
study to evaluate the safety and immunogenicity of sars-cov-2 vaccine (in-b009) in healthy adults (covid-19)

Conditions: COVID-19

Summary: this is a first in human, phase i, open-label, dose-escalation study to assess the safety, reactogenicity, and immunogenicity of a sars-cov-2 vaccine (in-b009) in healthy adults.

total of 40 participants will be enrolled in 3 institutions : seoul national university hospital, jeonbuk national university hospital, and chungbuk national university hospital. safety, reactogenicity, and immunogenicity will be evaluated in healthy participants with administration of in-b009 (injected twice, 21-day-interval).

Eligibility criteria:
inclusion criteria: * male or female participants between the ages of 18 and 55 years. * participants considered 'healthy' to be eligible for study participation. * participants who are willing and able to comply with all scheduled visits and other study procedures. * participants with body mass index (bmi) within the normal range. * participants with deltoid muscle capable of ip injection. * those that agreed to using medically approved contraception. * female participants with potential pregnancy- those that used medically approved contraception and has negative result at the pregnancy test. * capable of giving personal signed informed consent exclusion criteria: * clinically significant symptoms prior to ip injection. * confirmed to be covid-19 rt-pcr positive or to have made close contact with sars-cov-2 infected patient. * history of virologically-confirmed sars, mers, or covid-19. * history of congenital or acquired immunodeficiency or autoimmune diseases. * positive result of hepatitis b, c, rpr test, or hiv. * history of disorder that inhibits intramuscular injection of the vaccine. * history of hypersensitivity and severe allergic reaction to any of the components of ip. * history of malignant tumor within 5 years prior to the first ip injection. * clinically significant chronic diseases that could cause safety concerns regarding covid-19. * scheduled of , or history of surgery under general anaesthesia prior to first ip injection, * female participant that is pregnant or is currently breastfeeding. * smoker or history of smoking within 12 weeks prior to first ip injection. * previous vaccination or treatment for prevention of covid-19. * vaccination prior to the first ip injection or scheduled of vaccination after second ip injection. * treated with immunoglobulin and/or blood/blood components prior to first ip injection. * chronic use of immunosuppressant prior to first ip injection. * participated in other clinical study prior to first ip injection, or scheduled to participate in other study during the study period. * healthcare worker or emergency response personnel. * conditions that may influence the evaluation of the study objectives.
a phase ii clinical study of lidocain pertubation as treatment for couples with unexplained infertility

Conditions: Infertility

Summary: the study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.

in a prospective study, patients were randomized during a clomiphene citrate stimulated cycle to either pertubation with low-dose lidocain or no pertubation before insemination.

Eligibility criteria:
inclusion criteria: * female, * 20-40 years of age, * if presence of peritoneal endometriosis they must be of minimal or mild without adhesions (verified by laparoscopy), * normal menstruation cycle, * male partner 20-70 years of age, * male partner, * normal sperm sample within 5 years (\>20x106/ml, total sperm count \>30x106, normal morphology 5%), * duration of infertility more than one year, * signed informed consent exclusion criteria: * treatment with nsaid, corticosteroids or other drugs, which can cause an increased risk of infection, * clinical signs of pid, * known hypersensitivity to local anesthetics, * non-patent fallopian tubes, * pathological uterine cavity, * pathological pct, myoma \> 2 cm diameter, * any disease or laboratory finding considered of importance by the investigator not to include the patient

Keywords: pertubation, tubal flushing, intrauterine insemination.
cystic fibrosis and cognitive function

Conditions: Cystic Fibrosis

Summary: the long-term goal of this project is to examine the effects of cystic fibrosis (cf) and cystic fibrosis related diabetes (cfrd) on brain structure and function

a growing body of evidence suggests that hyperglycemia in type 1 and type 2 diabetes is associated with alterations in brain structure and cognitive impairment. people with cystic fibrosis related diabetes (crfd) are exposed to hyperglycemia as seen in other forms of diabetes, and cystic fibrosis is also associated with chronic systemic inflammation. both hyperglycemia and chronic inflammation have been postulated to affect brain structure and function. cystic fibrosis trans-membrane conductance regulator (cftr). protein is widely expressed in the neurons of the brain including in the hippocampus the hippocampus plays an essential role in learning and memory processing and is thought to be particularly vulnerable to effects of metabolic stressors. the expression of cftr in neurons has several potential implications for central nervous system function, including cognition. the long-term goal of this project is to examine the effects of cystic fibrosis (cf) and cystic fibrosis related diabetes (cfrd) on brain structure and function.

Eligibility criteria:
inclusion criteria: patients with cystic fibrosis exclusion criteria: * history of stroke * history of epilepsy * history of neurosurgical procedures * past or current history of severe psychiatric illness * pass or current history of alcohol or substance abuse * presence of metallic substances in body or inability to remove before imaging procedure * history of claustrophobia or known inability to tolerate mri * current pregnancy * inability to consent

Keywords: cfrd cystic fibrosis
experiences and perceived needs among parents of children exposed to potentially traumatic events: a qualitative inquiry

Conditions: Post Traumatic Stress Disorder

Summary: this study aims at exploring qualitatively experiences and perceived needs among parents of children exposed to potentially traumatic events, including their attitudes and understanding of trauma and resilience, their perceptions of their parental role in the peri-traumatic period, and their expectations of a family intervention for post-traumatic stress. this will ultimately guide future research to develop and design and intervention that would be tailored to their needs and expectations


Eligibility criteria:
inclusion criteria: * being a parent of a child aged 7-17 * exposed or who recently revealed a potentially traumatic event in the past six months exclusion criteria: abusive parent child and/or parent with intellectual deficiency

Keywords: post traumatic stress child and adolescent psychiatry parental perceived needs
a randomized controlled study of conservative treatment of granulomatous lobular mastitis combined with psychiatric disorders

Conditions: Breast Diseases; Mastitis Granulomatous; Psychiatric Disorder

Summary: granulomatous lobular mastitis (glm) is a relatively rare chronic inflammatory disease of the breast in clinical practice. a small number of patients develop hyperprolactinemia during psychiatric drug treatment, and most of these patients are nulliparous. at present, there is no unified treatment mode at home and abroad, and surgery is generally the main treatment. glm is a sterile inflammation, and glucocorticoids and methotrexate can effectively relieve clinical symptoms and even reach the standard of cure. in order to reduce the recurrence rate and protect the breast appearance as much as possible, we propose a conservative therapy. the purpose of this study was to compare this conservative therapy of granulomatous lobular mastitis with existing surgical treatment, and to compare the overall benefits of the two for patients with glm. we aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of glm patients with psychiatric disorders .


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older with granulomatous lobular mastitis * patients with psychiatric disorders; * patients volunteered to participate in the study after informed consent. exclusion criteria: * patients were diagnosed with mastitis with other definite etiology confirmed by pathology * patients in acute exacerbation of mental illness

Keywords: granulomatous lobular mastitis ；psychiatric disorder；steroid
pilot digital follow-up of lung cancer

Conditions: Lung Cancer

Summary: in the pilot study, 30 patients with metastatic lung cancer (stage iv) will be recruited at the start of their stage iv treatment from february 2019. the study period per patient will last six months, from the start of the stage iv treatment. patients are eligible if they are diagnosed with stage iv lung cancer, speak sufficient dutch, and are willing to participate. patients are randomly assigned to two arms by simple randomization. in the intervention arm, 15 patients will receive a weekly questionnaire. alerts will be sent to the multidisciplinary care team, who will undertake follow-up actions. in the control arm, 15 patients will receive the standard care pathway without weekly questionnaire and without automatic alerts to the care team. the standard care pathways and the care team are the same in both groups. in this pilot study, the weekly follow-up will be evaluated by a validation questionnaire, semi-structured interviews with patients (n=5) and the care team (n=5), and workload registration of the care team during a six-month period for all included patients in the pilot.


Eligibility criteria:
inclusion criteria: * stage iv lung cancer, * speak sufficient dutch * willing to participate exclusion criteria: -
exploration of the volatolom in the stable severe copd (chronic obstructive pulmonary disease)

Conditions: Chronic Obstructive Pulmonary Disease Severe

Summary: this is a prospective interventional study to determine whether the profile of volatile organic compounds (vocs) present in exhaled air (volatolom) is reproducible in stable severe copd (chronic obstructive pulmonary disease) patients.

after being informed about the study, all patients giving written informed consent and meeting the eligibility criteria will undergo 4 visits spaced 4 to 6 weeks apart. the first visit v1 will be about 45 minutes duration. the others ones (v2 to v4) will be about 30 minutes duration. all sessions will be carried out in the pneumology department of the foch hospital, volatolomics platform (exhalomics®). exhalation collection will be performed at each visit in order to perform the volatolom analysis.

Eligibility criteria:
inclusion criteria: 1. severe copd (fev ≤ 50% of theoretical values) * stable for at least two months, * treated for at least one year with one (or more successively) combination of at least two inhaled drugs: either a long-acting beta2-adrenergic bronchodilator (laba) combined with a corticosteroid (csi), or a laba combined with a long-acting anti-cholinergic bronchodilator (lama), or a triple combination laba/lama/csi; 2. history of at least one severe copd exacerbation (treated with antibiotics and / or oral corticosteroid therapy) in the two years preceding the study; 3. ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years 4. severe dyspnea at baseline (mmrc stage ≥ 2) 5. aged 40-85 years inclusive 6. fluency in french 7. a signed and dated written informed consent is obtained prior to participation 8. affiliated to a health insurance plan exclusion criteria: 1. severe exacerbation in the 4 months preceding the study 2. chronic inflammatory disease (rheumatic, etc.) treated with long-term systemic corticosteroid therapy, 3. long-term oxygen therapy (exclusive ambulatory oxygen therapy is not a non-inclusion criterion) 4. unstable cardiovascular pathology (right or left heart failure, coronary artery disease); 5. cancer 6. pregnant women; 7. deprived of liberty or under guardianship.

Keywords: chronic obstructive pulmonary disease (copd) volatile organic compounds (voc) severe stable
digital biofeedback system versus conventional home-based rehabilitation after total hip replacement

Conditions: Hip Osteoarthritis; Hip Arthrosis

Summary: the study was designed to compare the clinical outcomes of a home-based rehabilitation program using a novel digital biofeedback system against conventional home-based rehabilitation after total hip replacement this system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team. the investigators hypothesise that the clinical outcomes of a home-based rehabilitation program will be at least similar to the outcomes of a traditional home-based rehabilitation with face-to-face sessions. this is a single-center, prospective, parallel-group pilot study with active comparator. patients will be enrolled pre-operatively and then divided into 2 groups: experimental group and conventional rehabilitation group. both groups will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery. the experimental group will perform daily exercise sessions at home using the system, under remote monitoring from a physical therapist. the conventional rehabilitation group will perform 3 home-based rehabilitation sessions per week, each with 1h duration, given by a physical therapist. outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. the primary outcome is the change in patient performance measured by the timed-up-and-go (tug) test between in comparison with the pre-operative score. secondary outcomes will be measured in terms of: a) hip osteoarthritis outcome score (hoos); b) range of motion of the hip joint (lying flexion/abduction; standing flexion/adbuction/hyperextension)


Eligibility criteria:
inclusion criteria: * patients over 18 years old * clinical and imaging evidence of hip osteoarthritis * indication for total hip replacement according to the patient´s orthopedic surgeon * ability to walk unaided, with unilateral or bilateral support * availability of a carer to assist the patient after surgery exclusion criteria: * patients admitted for revision of total hip replacement * contralateral hip or knee osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program * aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process * respiratory, cardiac, metabolic or other condition incompatible with at least 30 minutes of light to moderate physical activity * major medical complications occurring after surgery that prevent the discharge of the patient within 7 days after the surgery * other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program * blind and/or illiterate patients